{"title":"VIDAS® TB-IGRA assay for diagnosing tuberculosis infection in people living with HIV: A preliminary study","authors":"Aliasgar Esmail , Jeremi Swanepoel , Suzette Oelofse , Brandon Reyneke , Anil Pooran , Shameem Jaumdally , Lara Wiese , Keertan Dheda","doi":"10.1016/j.ijid.2025.107955","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>The diagnosis of presumed latent tuberculosis (TB) infection (LTBI) is problematic in people living with HIV (PLWH) because of sub-optimal sensitivity and high indeterminate rates, especially in those with advanced immunosuppression. Better diagnostic tools for LTBI are needed in this sub-population.</div></div><div><h3>Methods</h3><div>We compared the sensitivity of VIDAS TB-IGRA, a fully automated RD1-specific new interferon-ϒ-release assay (IGRA), to QFT-Plus in 77 PLWH with active pulmonary TB who had varying CD4 counts. Sputum culture positivity served as the reference standard for active TB.</div></div><div><h3>Results</h3><div>The sensitivity of VIDAS TB-IGRA was similar to QFT-Plus overall [90.9% (70/77) vs 92.0% (69/75)], in those with CD4 <200 cells/mm<sup>3</sup>, [88.9% (40/45) vs 88.6% (39/44)], and in those with CD4 <100 [85.7% (18/21) vs 80.0% (16/20)]. However, VIDAS TB-IGRA had a higher sensitivity in those with CD4 <50 [92.3% (12/13) vs 75% (9/12)] and fewer indeterminate results overall [0 vs 2]. When the indeterminate results in this subgroup were regarded as negative, the comparative sensitivity was [92.3% (12/13) vs 69.2% (9/13)].</div></div><div><h3>Conclusion</h3><div>VIDAS TB-IGRA had a similar sensitivity to QFT-Plus in PLWH. Whether VIDAS TB-IGRA sensitivity is significantly better at lower CD4 counts remains to be confirmed in a larger study. These data have implications for the diagnosis of LTBI in those with advanced immunosuppression.</div></div>","PeriodicalId":14006,"journal":{"name":"International Journal of Infectious Diseases","volume":"158 ","pages":"Article 107955"},"PeriodicalIF":4.8000,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Infectious Diseases","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1201971225001791","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
Abstract
Background
The diagnosis of presumed latent tuberculosis (TB) infection (LTBI) is problematic in people living with HIV (PLWH) because of sub-optimal sensitivity and high indeterminate rates, especially in those with advanced immunosuppression. Better diagnostic tools for LTBI are needed in this sub-population.
Methods
We compared the sensitivity of VIDAS TB-IGRA, a fully automated RD1-specific new interferon-ϒ-release assay (IGRA), to QFT-Plus in 77 PLWH with active pulmonary TB who had varying CD4 counts. Sputum culture positivity served as the reference standard for active TB.
Results
The sensitivity of VIDAS TB-IGRA was similar to QFT-Plus overall [90.9% (70/77) vs 92.0% (69/75)], in those with CD4 <200 cells/mm3, [88.9% (40/45) vs 88.6% (39/44)], and in those with CD4 <100 [85.7% (18/21) vs 80.0% (16/20)]. However, VIDAS TB-IGRA had a higher sensitivity in those with CD4 <50 [92.3% (12/13) vs 75% (9/12)] and fewer indeterminate results overall [0 vs 2]. When the indeterminate results in this subgroup were regarded as negative, the comparative sensitivity was [92.3% (12/13) vs 69.2% (9/13)].
Conclusion
VIDAS TB-IGRA had a similar sensitivity to QFT-Plus in PLWH. Whether VIDAS TB-IGRA sensitivity is significantly better at lower CD4 counts remains to be confirmed in a larger study. These data have implications for the diagnosis of LTBI in those with advanced immunosuppression.
期刊介绍:
International Journal of Infectious Diseases (IJID)
Publisher: International Society for Infectious Diseases
Publication Frequency: Monthly
Type: Peer-reviewed, Open Access
Scope:
Publishes original clinical and laboratory-based research.
Reports clinical trials, reviews, and some case reports.
Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases.
Emphasizes diseases common in under-resourced countries.